Digital Therapeutics Research on Efficiency About Mild Cognitive Impairment Study

NCT05938426 | Active Not Recruiting

• 1 other identifier: EMC-ET-101
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficiency and safety of a digital therapeutics(ET-101) for mild cognitive impairment (MCI). This is a randomized, sham-controlled, assessor-blinded, 24-week parallel study. 100 MCI patients will be randomly assigned to two groups. The control group will be provided with a sham device.

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects with the same or reduced ADAS-cog14 score

  The 14 items of Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog14): Total scores range from 0 to 90, with higher scores indicating more worsening. Compare the proportion of subjects with the same or reduced ADAS-cog14 score between ET-101 and Sham group.

  Baseline compared to month 6 (24 weeks)

Secondary Outcomes (11)

• Proportion of subjects with the same or reduced ADAS-cog14 score

  Baseline compared to month 3 (12 weeks), month 3 compared to month 6 (12 weeks)

• Change in ADAS-cog14 total score

  Baseline compared to month 3 (12 weeks), Baseline compared to month 6 (24weeks), month 3 compared to month 6 (12 weeks)

• Proportion of subjects with decreased ADAS-Cog scores each at 0, 1, 2, 3, 4, 5 or more points.

  Baseline compared to month 3 (12 weeks), Baseline compared to month 6 (24weeks), month 3 compared to month 6 (12 weeks)

• Proportion of subjects with increased K-MMSEII score

  Baseline compared to month 3 (12 weeks), Baseline compared to month 6 (24weeks), month 3 compared to month 6 (12 weeks)

• Change in CDR-SB

  Baseline compared to month 3 (12 weeks), Baseline compared to month 6 (24weeks), month 3 compared to month 6 (12 weeks)

Other Outcomes (1)

• Adverse events rate

  12 weeks

Study Arms (2)

ET-101

ACTIVE COMPARATOR

Treatment group

Device: ET-101

Sham Device

SHAM COMPARATOR

Sham group

Device: Sham Device

Interventions

ET-101 DEVICE

Patients have training sessions twice a day. Each training session takes about 10\~25 minutes. Cognitive training programs include meditation, cognitive training, and cognitive testing.

ET-101

Sham Device DEVICE

Sham device has only cognitive function test excluding training programs.

Sham Device

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• Patients diagnosed with mild cognitive impairment according to Petersen criteria
• A person with subjective memory complaints
• Memory degradation of z-score ≤ -1 from the normal range of age, gender, and level of education in the memory area of the CREAD-NP or SNSB battery
• The functional performance of overall cognitive function and daily life ability is sufficiently preserved.
• Not dementia
• MMSE 27 or less
• Adequate vision and hearing for clinical trial
• Global CDR 0.5
• If approved AD treatment drugs(AChEI, memantine, or both) are being administered, they should be administered at a stable dose for at least 12 weeks prior to randomization.
• Have an identified trial partner (defined as someone who can assist the subject during the trial and spends at least 8 hours per week with the subject). The test partner must provide informed consent. This partner must also be willing and able to provide follow-up information to the subject during the trial. In the opinion of the investigator, the trial partner should spend sufficient time with the subject on a regular basis to ensure that the trial requirements are met. The permanent study partner does not have to live in the same residence as the subject. For study partners not residing with the subject, the investigator should ensure that the subject can easily contact the study partner while the study partner is not with the subject. If it is uncertain whether a subject's care arrangement is suitable for selection, the investigator should discuss this with the Medical Monitor. The trial partner should participate directly in visits where the clinical evaluation of CDR, EQ-5D, ADCS MCI-ADL are performed.
• No difficulty in using mobile applications using smartphone
• A person who owns his/her smartphone
• A person who can call his/her guardian using smartphone by himself/herself
• No difficulty in reading and writing Korean

You may not qualify if:

• History of a transient ischemic attack(TIA), stroke, seizure within 12 months
• Psychiatric symptoms that include;
• History of diagnosis of psychiatric disorders or symptoms that may interfere with the subject's testing procedure (e.g., psychosis, major depression)
• Responding "yes" to item 4 or 5 to suicidal ideation part of C-SSRS or any suicidal behavior within 6 months prior to screening, at screening or at randomization visit, or being hospitalized or treated for suicidal behavior in the past 5 years prior to screening
• All other clinically significant abnormalities, such as
• Physical examinations, neurological examinations, and vital signs at screening or baseline that, in the opinion of the investigator, may require additional examination or treatment that may interfere with the study procedure or safety
• Other medical conditions (e.g., heart, respiratory, gastrointestinal, kidney disease) that are not adequately stable controlled or that, in the investigator's opinion, may affect the safety of the subject or interfere with the evaluation of the trial
• A known or suspected history of drug or alcohol abuse or dependence within 2 years prior to screening
• Prohibited concomitant medication
• Surgery that requires general anesthesia is scheduled during the trial period.If only local anesthesia is required and the surgery is the day case without hospitalization after surgery or if, in the opinion of the investigator, the operation does not interfere with the test procedure and the safety of the subject, they should not be excluded
• History of any type(online/offline) of cognitive intervention or participation in clinical trial regarding cognitive intervention within 12 months

Sponsors & Collaborators

• Emocog Inc.: lead

Study Sites (1)

Gachon University Gil Medical Center

Incheon, South Korea

Location

Related Publications (1)

• Kang S, Lim JI, Stenzel L, Kim KY, Kim E, Jeon HJ, Park DH, Lim HK, Shim Y, Jang JW, Kim Y, Lee S, Park KH. Efficacy and Safety of Mobile App-Based Metamemory Cognitive Training for Mild Cognitive Impairment: Multicenter Randomized Clinical Trial. JMIR Mhealth Uhealth. 2026 Jan 19;14:e73464. doi: 10.2196/73464.

  PMID: 41554532 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• KeeHyung Park

  Gachon University Gil Medical Center

  PRINCIPAL INVESTIGATOR

• JaeWon Jang

  KangWon National University Hospital

  PRINCIPAL INVESTIGATOR

• HongJun Jeon

  Konkuk University Medical Center

  PRINCIPAL INVESTIGATOR

• EoSu Kim

  Severance Hospital

  PRINCIPAL INVESTIGATOR

• HyunKook Lim

  Yeouido St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

• YongSoo Shim

  Eunpyeong St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

• KeunYou Kim

  SMG-SNU Boramae Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: July 10, 2023
• Study Start: June 8, 2023
• Primary Completion: March 31, 2024
• Study Completion: June 30, 2024
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)